Sr Manager, Quality Assurance
Senior Manager, Quality Assurance
📍 Aliso Viejo, CA (On-site)
A fast-growing med device company developing innovative minimally invasive vascular technologies is expanding its Quality leadership team amid strong commercial growth and pipeline advancement.
Why this role stands out
- Lead and scale the QMS in a company moving into commercialization
- High-impact role with executive visibility
- Support cutting-edge, life-saving vascular therapies
- Opportunity to build, refine, and elevate quality systems
Key focus areas
- Own QMS (FDA 21 CFR 820, ISO 13485)
- Drive CAPA, complaints, MDRs, audits
- Partner with R&D, Regulatory, and Ops
- Lead risk management (ISO 14971) & quality metrics
Background
- 7+ years in medical device quality
- Strong QMS / regulatory expertise
- Experience in fast-paced or growth-stage environments
This is a strong opportunity to step into a visible leadership role driving quality for a company bringing impactful vascular innovations to market.
If you feel you'd make a good fit for this role based on your background in Quality at the leadership level, please apply.
FAQs
Congratulations, we understand that taking the time to apply is a big step. When you apply, your details go directly to the consultant who is sourcing talent. Due to demand, we may not get back to all applicants that have applied. However, we always keep your resume and details on file so when we see similar roles or see skillsets that drive growth in organizations, we will always reach out to discuss opportunities.
Yes. Even if this role isn’t a perfect match, applying allows us to understand your expertise and ambitions, ensuring you're on our radar for the right opportunity when it arises.
We also work in several ways, firstly we advertise our roles available on our site, however, often due to confidentiality we may not post all. We also work with clients who are more focused on skills and understanding what is required to future-proof their business.
That's why we recommend registering your resume so you can be considered for roles that have yet to be created.
Yes, we help with CV and interview preparation. From customized support on how to optimize your CV to interview preparation and compensation negotiations, we advocate for you throughout your next career move.